Bioequivalence Study of Bicalutamide 50 mg Tablet and Casodex 50 mg Tablet in Healthy Subjects Under Fasting Conditions

This study has been completed.
Sponsor:
Collaborator:
Watson Laboratories, Inc.
Information provided by:
Kremers Urban Development Company
ClinicalTrials.gov Identifier:
NCT01039233
First received: December 23, 2009
Last updated: NA
Last verified: December 2009
History: No changes posted
  Purpose

The objective of this study is to compare the rate and extent of absorption of bicalutamide 50 mg tablet (test) versus Casodex (reference), administered as 1 x 50 mg tablet under fasting conditions


Condition Intervention Phase
Bioequivalency
Drug: Bicalutamide 50 mg Tablet vs Casodex® 50 mg Tablet
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized, Bioequivalence Study of Bicalutamide 50 mg Tablet and Casodex 50 mg Tablet Following a 50 mg Dose in Healthy Subjects Under Fasting Conditions

Resource links provided by NLM:


Further study details as provided by Kremers Urban Development Company:

Primary Outcome Measures:
  • AUC0-t (area under the concentration-time curve from time zero to time of last measurable concentration) [ Time Frame: 144 hour ] [ Designated as safety issue: No ]
  • AUC0-inf area under the concentration-time curve from time zero to infinity) [ Time Frame: 144 hour ] [ Designated as safety issue: No ]
  • Cmax (maximum observed concentration of drug substance in plasma) [ Time Frame: 144 hour ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: May 2005
Study Completion Date: July 2005
Primary Completion Date: June 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bicalutamide 50 mg Tablet Drug: Bicalutamide 50 mg Tablet vs Casodex® 50 mg Tablet
Active Comparator: Casodex® 50 mg Tablet Drug: Bicalutamide 50 mg Tablet vs Casodex® 50 mg Tablet

  Eligibility

Ages Eligible for Study:   20 Years to 73 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male, non-smoker, 18 years of age and older;
  • Capable of consent;
  • BMI≥19.0 and <30.0 kg/m2.

Exclusion Criteria:

  • Clinically significant illnesses within 4 weeks prior to the administration of the study medication.
  • Clinically significant surgery within 4 weeks prior to the administration of the study medication.
  • Any clinically significant abnormality found during medical screening.
  • Any reason which, in the opinion of the Medical Sub-Investigator, would prevent the subject from participating in the study.
  • Abnormal laboratory tests judged clinically significant.
  • Positive testing for hepatitis B, hepatitis C, or HIV at screening.
  • ECG abnormalities (clinically significant) or vital sign abnormalities (systolic blood pressure lower than 90 or over 140 mmHg, diastolic blood pressure lower than 50 or over 90 mmHg, or heart rate less than 50 or over 100 bpm) at screening.
  • History of significant alcohol abuse or drug abuse within one year prior to the screening visit.
  • Regular use of alcohol within six months prior to the screening visit (more than fourteen units of alcohol per week [1 Unit = 150 mL of wine, 360 mL of beer, or 45 mL of 40% alcohol]).
  • Use of soft drugs (such as marijuana) within 3 months prior to the screening visit or hard drugs (such as cocaine, phencyclidine [PCP] and crack) within 1 year prior to the screening visit or positive urine drug screen at screening.
  • Use of any drugs known to induce or inhibit hepatic drug metabolism (examples of inducers: barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole; examples of inhibitors: antidepressants (SSRI), cimetidine, diltiazem, macrolides, imidazoles, neuroleptics, verapamil, fluoroquinolones, antihistamines) within 30 days prior to administration of the study medication.
  • Use of an investigational drug or participation in an investigational study within 30 days prior to administration of the study medication.
  • Clinically significant history or presence of any clinically significant gastrointestinal pathology (e.g. chronic diarrhea, inflammatory bowel diseases), unresolved gastrointestinal symptoms (e.g. diarrhea, vomiting), liver or kidney disease, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of the drug.
  • Any clinically significant history or presence of clinically significant neurological, endocrinal, cardiovascular, pulmonary, hematologic, immunologic, psychiatric, or metabolic disease.
  • Use of prescription medication within 14 days prior to administration of study medication or over-the-counter products (including natural food supplements, vitamins. garlic as a supplement) within 7 days prior to administration of study medication, except for topical products without systemic absorption.
  • Difficulty to swallow study medication.
  • Use of any tobacco products in the 6 months preceding drug administration.
  • Any food allergy, intolerance, restriction or special diet that, in the opinion of the Medical Sub-Investigator, could contraindicate the subject's participation in this study.
  • A depot injection or an implant of any drug within 3 months prior to administration of study medication.
  • Donation of plasma (500 mL) within 7 days prior to drug administration. Donation or loss of whole blood (excluding the volume of blood that will be drawn during the screening procedures of this study) prior to administration of the study medication as follows:

    • 50 mL to 300 mL of whole blood within 30 days,
    • 301 mL to 500 mL of whole blood within 45 days, or
    • more than 500 mL of whole blood within 56 days prior to drug administration.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01039233

Locations
Canada, Quebec
SFBC Anapharm
Montreal, Quebec, Canada, H3X 2H9
Sponsors and Collaborators
Kremers Urban Development Company
Watson Laboratories, Inc.
Investigators
Principal Investigator: Richard Larouche, M.D. SFBC Anapharm
  More Information

No publications provided

Responsible Party: Richard Larouche, M.D., Medical Director, sfbc Anapharm
ClinicalTrials.gov Identifier: NCT01039233     History of Changes
Other Study ID Numbers: 50013
Study First Received: December 23, 2009
Last Updated: December 23, 2009
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Bicalutamide
Androgen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 26, 2014